To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.

In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA >= 400 copies/ml (by PCR on two occasions >= 1 week and < 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir.

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

GM-CSF, G-CSF, and erythropoietin.

Concurrent Treatment:

Allowed:

Local treatment for Kaposi's sarcoma.

Patients must have:

HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.

Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually.

Patients with the following prior conditions are excluded:

History of relevant pancreatitis or hepatitis in the last 6 months.

Prior Medication:

Excluded:

Cytotoxic chemotherapeutic agents within 30 days of study drug administration.

Prior antiretroviral therapy.

HIV vaccine dose within 90 days of study drug administration.

Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry.

Prior Treatment:

Excluded:

Radiation therapy within 30 days of study drug administration.

Current alcohol or illicit drug use that may interfere with patient compliance.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002199